Tutkimus Amivantamabista ja FOLFIRIsta versus setuksimabi/bevasitsumabi ja FOLFIRI KRAS/NRAS- ja BRAF-villityypin paksusuolensyöpää sairastavilla, jotka ovat aiemmin saaneet kemoterapiaa (OrigAMI-3)
Satunnaistettu, avoin vaiheen 3 tutkimus Amivantamab + FOLFIRI versus setuksimabi/bevasitsumabi + FOLFIRI osallistujilla, joilla on KRAS/NRAS ja BRAF villityypin uusiutuva, leikkaukseen kelpaamaton tai metastaattinen kolorektaalisyöpä, jotka ovat saaneet aikaisempaa kemoterapiaa
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 3
Laajennettu käyttöoikeus
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Study Contact
- Puhelinnumero: 844-434-4210
- Sähköposti: Participate-In-This-Study1@its.jnj.com
Opiskelupaikat
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Amersfoort, Alankomaat, 3813 TZ
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Amsterdam, Alankomaat, 1066 CX
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Nijmegen, Alankomaat, 6525 GA
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Rotterdam, Alankomaat, 3015 GD
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Tilburg, Alankomaat, 5042 AD
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Concord, Australia, 2139
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Heidelberg, Australia, 3084
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South Woodville, Australia, 5011
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St Albans, Australia, 3021
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Anderlecht, Belgia, 1070
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Ghent, Belgia, 9000
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Haine Saint Paul La Louviere, Belgia, 7100
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Kortrijk, Belgia, 8500
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Leuven, Belgia, 3000
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Liège, Belgia, 4000
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Barretos, Brasilia, 14780 070
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Caxias do Sul, Brasilia, 95070 560
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Porto Alegre, Brasilia, 91350 200
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Barcelona, Espanja, 08003
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Barcelona, Espanja, 08041
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Barcelona, Espanja, 08035
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Madrid, Espanja, 28034
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Madrid, Espanja, 28041
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Málaga, Espanja, 29010
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Pamplona, Espanja, 31008
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Seville, Espanja, 41013
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Valencia, Espanja, 46010
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Daegu, Etelä -Korea, 41404
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Seoul, Etelä -Korea, 05505
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Seoul, Etelä -Korea, 03080
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Seoul, Etelä -Korea, 06351
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Seoul, Etelä -Korea, 02841
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Seoul, Etelä -Korea, 03722
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Seoul, Etelä -Korea, 06591
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Hong Kong, Hong Kong
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Shatin, Hong Kong
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Delhi, Intia, 110085
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Hyderabad, Intia, 500032
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Kolkata, Intia, 700053
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Mumbai, Intia, 400012
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Pune, Intia, 411004
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Beer Yaakov, Israel, 70300
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Petah Tikva, Israel, 4941492
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Ramat Gan, Israel, 52621
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Tel Aviv, Israel, 6423906
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Tel Aviv, Israel, 69710
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Catania, Italia, 95122
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Florence, Italia, 50134
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Milan, Italia, 20133
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Novara, Italia, 28100
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Padova, Italia, 35128
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Pisa, Italia, 56126
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Rozzano, Italia, 20089
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Udine, Italia, 33100
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Chiba, Japani, 260 0801
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- Chiba Cancer Center
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Chūōku, Japani, 104 0045
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- National Cancer Center Hospital
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Kashiwa, Japani, 277 8577
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- National Cancer Center Hospital East
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Nagoya, Japani, 464-8681
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- Aichi Cancer Center
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Osaka, Japani, 541 8567
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- Osaka International Cancer Institute
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Osaka, Japani, 540 0006
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- National Hospital Organization Osaka National Hospital
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Sakai, Japani, 590 0197
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Shizuoka, Japani, 411 8777
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Suita, Japani, 565 0871
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- The University of Osaka Hospital
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Tokyo, Japani, 135 8550
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Beijing, Kiina, 100142
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Beijing, Kiina, 100034
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Beijing, Kiina, 100050
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Changchun, Kiina, 130021
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Changsha, Kiina, 410013
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Chengdu, Kiina, 610041
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Ganzhou, Kiina, 341000
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Guangzhou, Kiina, 510655
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Guangzhou, Kiina, 519041
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Guangzhou, Kiina, 100142
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Hangzhou, Kiina, 310022
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Hangzhou, Kiina, 310009
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Harbin, Kiina, 150081
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Huizhou, Kiina, 516001
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Lanzhou, Kiina, 730050
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Nanchang, Kiina, 330006
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Shanghai, Kiina, 200032
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Shenyang, Kiina, 110042
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Tianjin, Kiina, 300060
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Wuhan, Kiina, 430079
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George Town, Malesia, 10450
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Ipoh, Malesia, 30450
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Kuala Lumpur, Malesia, 59100
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Kuala Lumpur, Malesia, 50586
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Kuching, Malesia, 93586
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Putrajaya, Malesia, 62250
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Chihuahua City, Meksiko, 31217
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Guadalajara, Meksiko, 44680
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Mexico City, Meksiko, 14080
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Mexico City, Meksiko, 06760
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Monterrey, Meksiko, 64460
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Puebla City, Meksiko, 72530
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Querétaro, Meksiko, 76000
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Querétaro, Meksiko, 76230
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Tijuana, Meksiko, 22010
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San Juan, Puerto Rico, 00935
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Bialystok, Puola, 15 027
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Craiova, Romania, 200542
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Iași, Romania, 700483
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Gothenburg, Ruotsi, 413 45
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Berlin, Saksa, 13353
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Kaohsiung City, Taiwan, 833
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Istanbul, Turkki (Türkiye), 34899
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30322
- Rekrytointi
- Winship Cancer Institute Emory University
-
-
Illinois
-
Arlington Heights, Illinois, Yhdysvallat, 60005
- Rekrytointi
- Illinois Cancer Specialists
-
Peoria, Illinois, Yhdysvallat, 61615
- Rekrytointi
- Illinois CancerCare
-
-
Indiana
-
Indianapolis, Indiana, Yhdysvallat, 46237
- Rekrytointi
- Franciscan Health
-
-
Iowa
-
Iowa City, Iowa, Yhdysvallat, 52242
- Rekrytointi
- University of Iowa Hospitals and Clinics
-
Waukee, Iowa, Yhdysvallat, 50263
- Rekrytointi
- Mission Cancer Blood
-
-
Kansas
-
Wichita, Kansas, Yhdysvallat, 67214
- Rekrytointi
- Cancer Center of Kansas
-
-
Louisiana
-
Baton Rouge, Louisiana, Yhdysvallat, 70809
- Rekrytointi
- Mary Bird Perkins Cancer Center
-
-
Maryland
-
Baltimore, Maryland, Yhdysvallat, 21237
- Rekrytointi
- MedStar Franklin Square Medical Center
-
Frederick, Maryland, Yhdysvallat, 21702
- Rekrytointi
- Frederick Health Hospital - James M Stockman Cancer Institute
-
-
Michigan
-
Ann Arbor, Michigan, Yhdysvallat, 48109
- Rekrytointi
- University of Michigan Rogel Cancer Center
-
Detroit, Michigan, Yhdysvallat, 48202
- Rekrytointi
- Henry Ford Hospital
-
Grand Rapids, Michigan, Yhdysvallat, 49503
- Rekrytointi
- Cancer And Hematology Centers of Western Michigan PC
-
-
Mississippi
-
Hattiesburg, Mississippi, Yhdysvallat, 39401
- Rekrytointi
- Hattiesburg Clinic
-
-
Missouri
-
St Louis, Missouri, Yhdysvallat, 63110
- Rekrytointi
- Washington University School Of Medicine
-
-
Nebraska
-
Omaha, Nebraska, Yhdysvallat, 68130
- Rekrytointi
- Nebraska Cancer Specialists
-
-
New Jersey
-
East Brunswick, New Jersey, Yhdysvallat, 08816
- Rekrytointi
- Astera Cancer Care
-
-
New York
-
Mineola, New York, Yhdysvallat, 11501
- Rekrytointi
- Perlmutter Cancer Center at NYU Long Island
-
New York, New York, Yhdysvallat, 10016
- Rekrytointi
- NYU Langone Medical Center NYU Hematology Associates
-
Shirley, New York, Yhdysvallat, 11967
- Rekrytointi
- New York Cancer and Blood Specialists
-
The Bronx, New York, Yhdysvallat, 10461
- Rekrytointi
- Montefiore Einstein Comprehensive Cancer Center
-
Williamsville, New York, Yhdysvallat, 14221
- Rekrytointi
- University of Buffalo Kaleida Health Cancer Care
-
-
Ohio
-
Canton, Ohio, Yhdysvallat, 44718
- Rekrytointi
- Gabrail Cancer Center
-
Cleveland, Ohio, Yhdysvallat, 44106
- Rekrytointi
- University Hospital of Cleveland
-
-
Oregon
-
Portland, Oregon, Yhdysvallat, 97239
- Rekrytointi
- Oregon Health And Science University
-
-
Pennsylvania
-
Penn Wynne, Pennsylvania, Yhdysvallat, 19096
- Rekrytointi
- Alliance Cancer Specialists at Main Line
-
Philadelphia, Pennsylvania, Yhdysvallat, 19111
- Rekrytointi
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Yhdysvallat, 19107
- Rekrytointi
- Thomas Jefferson University
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15232 1301
- Rekrytointi
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
-
-
Tennessee
-
Chattanooga, Tennessee, Yhdysvallat, 37404
- Rekrytointi
- Tennessee Oncology Chattanooga
-
Nashville, Tennessee, Yhdysvallat, 37232
- Rekrytointi
- Vanderbilt University Medical Center
-
Nashville, Tennessee, Yhdysvallat, 37203
- Rekrytointi
- Tennessee Oncology
-
Nashville, Tennessee, Yhdysvallat, 37203
- Rekrytointi
- SCRI Oncology Partners
-
-
Texas
-
Abilene, Texas, Yhdysvallat, 79606
- Rekrytointi
- Texas Oncology West Texas
-
Dallas, Texas, Yhdysvallat, 75390
- Rekrytointi
- UT Southwestern Medical Center
-
Dallas, Texas, Yhdysvallat, 75235
- Rekrytointi
- Parkland Health and Hospital System
-
Dallas, Texas, Yhdysvallat, 75246
- Rekrytointi
- Texas Oncology DFW
-
Houston, Texas, Yhdysvallat, 77030
- Rekrytointi
- MD Anderson Cancer Center
-
Round Rock, Texas, Yhdysvallat, 77845
- Rekrytointi
- Baylor Scott & White Medical Center
-
San Antonio, Texas, Yhdysvallat, 78240
- Rekrytointi
- Texas Oncology - San Antonio
-
Temple, Texas, Yhdysvallat, 76508
- Rekrytointi
- Scott And White Memorial Hospital
-
Tyler, Texas, Yhdysvallat, 75701
- Rekrytointi
- UT Health East Texas HOPE Cancer Center
-
-
Virginia
-
Arlington, Virginia, Yhdysvallat, 22201
- Rekrytointi
- Virginia Cancer Specialists
-
Richmond, Virginia, Yhdysvallat, 23249
- Rekrytointi
- Richmond VA Medical Center
-
Richmond, Virginia, Yhdysvallat, 23298
- Rekrytointi
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Lacey, Washington, Yhdysvallat, 98503
- Rekrytointi
- Providence Regional Cancer System
-
Seattle, Washington, Yhdysvallat, 98109
- Rekrytointi
- Fred Hutchinson Cancer Research Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, Yhdysvallat, 53226
- Rekrytointi
- Medical College Of Wisconsin
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
- Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing
- Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible
- Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
- Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
- Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy
Exclusion Criteria:
- Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
- Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI
- Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments
- Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
- Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Arm A: Amivantamab + FOLFIRI
Participants will receive amivantamab along with FOLFIRI (consisting of 5-fluorouracil, leucovorin calcium [folinic acid] or levoleucovorin, and irinotecan) as a chemotherapy regimen for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met. |
Amivantamab will be administered.
Muut nimet:
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Muut nimet:
Irinotecan will be administered as chemotherapy regimen. |
|
Active Comparator: Arm B: Cetuximab or Bevacizumab + FOLFIRI
Participants will receive either cetuximab or bevacizumab along with FOLFIRI as a chemotherapy regimen for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met. |
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Muut nimet:
Cetuximab will be administered.
Muut nimet:
Irinotecan will be administered as chemotherapy regimen. Bevacizumab will be administered.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Aikaikkuna: Up to 2 years 1 month
|
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v)1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date. |
Up to 2 years 1 month
|
|
Overall Survival (OS)
Aikaikkuna: Up to 4 years 4 months
|
OS is defined as the time from the date of randomization to the date of participant's death due to any cause. |
Up to 4 years 4 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by BICR
Aikaikkuna: Up to 4 years 4 months
|
ORR is defined as the percentage of randomized participants achieving partial response (PR) or complete response (CR), as determined by BICR using RECIST v1.1 criteria. |
Up to 4 years 4 months
|
|
ORR as Assessed by Investigator
Aikaikkuna: Up to 4 years 4 months
|
ORR is defined as the percentage of randomized participants achieving partial response (PR) or complete response (CR), as determined by investigator using RECIST v1.1 criteria. |
Up to 4 years 4 months
|
|
Progression Free Survival as Assessed by Investigator
Aikaikkuna: Up to 4 years 4 months
|
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by investigator. |
Up to 4 years 4 months
|
|
Duration of Response (DoR) as Assessed by BICR
Aikaikkuna: Up to 4 years 4 months
|
DoR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR as assessed by BICR. |
Up to 4 years 4 months
|
|
Duration of Response as Assessed by Investigator
Aikaikkuna: Up to 4 years 4 months
|
DoR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR as assessed by investigator. |
Up to 4 years 4 months
|
|
Time to Response (TTR) as Assessed by BICR
Aikaikkuna: Up to 4 years 4 months
|
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by BICR. |
Up to 4 years 4 months
|
|
TTR as Assessed by Investigator
Aikaikkuna: Up to 4 years 4 months
|
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by investigator. |
Up to 4 years 4 months
|
|
Progression Free Survival After Subsequent Therapy (PFS2)
Aikaikkuna: Up to 4 years 4 months
|
PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent systemic anticancer therapy, based on investigator assessment or death, whichever comes first. |
Up to 4 years 4 months
|
|
Disease Control Rate (DCR) as Assessed by BICR
Aikaikkuna: Up to 4 years 4 months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with a minimum duration of 7 weeks) as defined by BICR using RECIST v1.1. |
Up to 4 years 4 months
|
|
Disease Control Rate as Assessed by Investigator
Aikaikkuna: Up to 4 years 4 months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with a minimum duration of 7 weeks) as assessed by investigator. |
Up to 4 years 4 months
|
|
Time to Treatment Failure
Aikaikkuna: Up to 4 years 4 months
|
Time to treatment failure is defined as time from randomization to discontinuation of therapy for any reason including death, progression, toxicity, or initiation of new anticancer therapy. |
Up to 4 years 4 months
|
|
Curative Resection (R0) Rate
Aikaikkuna: Up to 4 years 4 months
|
Curative resection (R0) rate is defined as the percentage of randomized participants who underwent curative-intent surgery where the residual tumor classification was R0. |
Up to 4 years 4 months
|
|
Number of Participants with Adverse Events (AEs) by Severity
Aikaikkuna: Up to 4 years 4 months
|
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE. |
Up to 4 years 4 months
|
|
Number of Participants with Abnormalities in Laboratory Values
Aikaikkuna: Up to 4 years 4 months
|
Participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported. |
Up to 4 years 4 months
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Aikaikkuna: From baseline up to 4 years 4 months
|
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status/quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms. |
From baseline up to 4 years 4 months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C30
Aikaikkuna: Up to 4 years 4 months
|
Time to worsening in symptoms and functioning as measured by EORTC QLQ-C30 score will be reported. The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms. |
Up to 4 years 4 months
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29) Score
Aikaikkuna: From baseline up to 4 years 4 months
|
The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ-CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms. |
From baseline up to 4 years 4 months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-CR29 Score
Aikaikkuna: Up to 4 years 4 months
|
Time to worsening in symptoms and functioning as measured by EORTC QLQ-CR29 will be reported. EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ-CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms. Change from baseline in the EORTC QLQ-CR29 score will be reported. |
Up to 4 years 4 months
|
|
Overall Side Effect Burden as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Item 168 Scale Score
Aikaikkuna: Up to 4 years 4 months
|
EORTC item 168 is a single item used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much. Higher scores indicates severe symptoms. |
Up to 4 years 4 months
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat sivustoittain
- Neoplasmat
- Suoliston sairaudet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan sairaudet
- Ruoansulatuskanavan sairaudet
- Suoliston kasvaimet
- Peräsuolen sairaudet
- Paksusuolen sairaudet
- Kolorektaaliset kasvaimet
- Aminohapot, peptidit ja proteiinit
- Proteiinit
- Heterosykliset yhdisteet, 1-rengas
- Heterosykliset yhdisteet
- Heterosykliset yhdisteet, 2-rengas
- Heterosykliset yhdisteet, sulatettu rengas
- Camptothecin
- Alkaloidit
- Entsyymit ja koentsyymit
- Vasta -aineet, monoklonaalinen, humanisoitu
- Vasta -aineet, monoklonaalinen
- Vasta -aineet
- Immunoglobuliinit
- Immunoproteiinit
- Veriproteiinit
- Seerumin globuliinit
- Globuliinit
- Pyrimidiinit
- Formyyltetrahydrofolaatit
- Tetrahydrofolaatit
- Foolihappo
- Pterinit
- Pteridiinit
- Urasiili
- Pyrimidinonit
- Koentsyymit
- Bevasitsumabi
- Irinotekaani
- Setuksimabi
- Fluorourasiili
- Leukovoriini
- Levoleukovoriini
- amivantamab
Muut tutkimustunnusnumerot
- 61186372COR3002
- 2024-513853-66-00 (Rekisterin tunniste: EUCT number)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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